ERP for Medical Device Companies
Compliance, quality, and traceability built-in, not bolted-onWhen a recall, complaint, or component issue lands, traceability needs to be operational, not a data extraction project. Rootstock makes lot, serial, and as-built lineage structural, so that the answer to “which units are affected?” is only one click or one question away.
Trusted by leading MedTech companies
ERP Built for FDA-Regulated Device Companies with as-built Traceability
Rootstock serves builders of medical devices, diagnostic equipment, and instrumentation operating under FDA QSR, EU MDR, and ISO 13485. For Class I, II, and selected Class III device companies running multi-entity, multi-country operations with documented design controls and as-built traceability requirements, Rootstock is the regulated-operations ERP that keeps audit-grade lineage structural.
Where Standard ERP Often Falls Short for MedTech Companies
Most ERPs weren't built for FDA-regulated operations. The work either lives in parallel systems or gets reconstructed when it matters most. You’re often left with:
Traceability that survives an inspection but not an audit
Design control and change management living in separate systems
Vendor-pushed updates that destabilize validated environments
Recall and MDR responses measured in days when the regulatory clock measures in minutes
Multi-country regulatory operations running as parallel implementations, not configurations
Loaner, consignment, and kit visibility split across spreadsheets and field-team memory
ERP Built for Regulated Med Tech Operations
Rootstock provides structural lot and serial traceability, document-controlled change management, and field-event responsiveness that match the regulatory and operational demands of medical device companies.
Traceability That's Audit-Ready by Default
Lot, serial, and as-built lineage are part of the data model, not an add-on or a parallel system. Every unit shipped traces back to which components, lots, and production orders produced it. Document-controlled change management captures who changed what, when, and why, so design updates and manufacturing changes carry their full audit trail in the same record. FDA QSR, EU MDR, ISO 13485, and country-specific UDI requirements run as regional configurations of one data model, not parallel implementations across geographies.
Recall Response in Minutes, Not Weeks
When a field event hits, the regulatory clock starts immediately. Ask an AI agent which devices shipped with component X between specific dates and get the answer in real-time, with affected customers, lots, and ship records surfaced. Closed-loop device service ties to kit management, loaner tracking, and consignment inventory, so the device, the customer, and the location stay on one record. Complaint and MDR response moves from a multi-day reconstruction project to a one-question conversation.
Validated Environments You Control
Rootstock does not push updates to your instance. You pull updates on your timeline, so the validated environment is never disturbed without your decision. For device companies on or moving to the Salesforce compliance ecosystem, a QMS integration delivers FDA 21 CFR Part 11, CAPA and NCR workflow, and measurement-based quality on top of the operations record. Shipped, not scoped.
Med Tech Companies Running on Rootstock
Customer Success Story: SPR Therapeutics
SPR Therapeutics, a medical device company specializing in neurostimulation, built an aggressive growth strategy. But its disconnected CRM, inventory, and quality systems were inefficient, underused critical data, and held that growth back. The company needed a technology foundation that would support its plan, not undermine it. See how SPR took a platform approach with Rootstock, ComplianceQuest, and Salesforce.
See Why Medical Device Companies Choose Rootstock
Whether you build Class I or Class II devices, diagnostic equipment, or specialty instrumentation, Rootstock keeps as-built lineage, design control, and field service on one regulated-operations record. So the next field event becomes a question with an answer, not a project.
